ClinicalTrials.gg
Not yet recruitingNCT07668544Updated Jun 25, 2026

Kinesiophobia and Functional Outcomes in Hand Injuries

An interventional study of Standard Surgical Treatment and Routine Postoperative Care in Hand Injuries, sponsored by Ebru Aloğlu Çiftçi. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Ebru Aloğlu Çiftçi · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Hand and forearm injuries are among the most common traumatic injuries and may result in substantial functional limitations, reduced work capacity, and decreased quality of life. Despite advances in surgical repair techniques, recovery outcomes vary considerably among individuals with similar injury characteristics. Psychological factors, particularly fear of movement or reinjury (kinesiophobia), may influence rehabilitation participation and functional recovery after injury.

The aim of this prospective observational study is to investigate the relationship between early kinesiophobia levels and functional outcomes in adults who undergo surgical treatment for traumatic hand or forearm lacerations. Kinesiophobia will be assessed during the acute post-injury period (within 1-5 days after injury) using the Tampa Scale of Kinesiophobia. Injury severity will be evaluated using the Modified Hand Injury Severity Classification (MHISC/MEYCS).

Participants will be followed for 12 weeks after injury. Functional recovery will be assessed at the 8th week using the Buck-Gramcko Score and the Sollerman Hand Function Test, and at the 12th week using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and hand grip strength measurements.

The study will examine whether higher levels of early kinesiophobia are associated with greater injury severity and poorer functional recovery. Findings from this study may help identify patients at risk for delayed recovery and support the development of early rehabilitation strategies targeting psychological as well as physical aspects of hand injury recovery.

02

Conditions studied

  • Hand Injuries

Keywords

  • kinesiophobia
  • functionality
03

In context

Hand Injuries

122 studies on the registry are indexed under Hand Injuries; 35 are open to participants now.

This study's planned enrollment of 100 is above the median of 55 across 97 interventional studies indexed under Hand Injuries.

Browse Hand Injuries studies →

Lead sponsor

Ebru Aloğlu Çiftçi is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Adults aged 18 years and older. Patients presenting to the emergency department with traumatic hand or forearm lacerations requiring surgical treatment.

Injury involving one or more anatomical structures of the hand or forearm (skin, tendon, nerve, vessel, or combined injuries).

Assessment within 1-5 days following injury. Ability to understand and complete study questionnaires and functional assessments.

Provision of written . Willingness to participate in follow-up assessments at 8 and 12 weeks after injury.

Exclusion criteria

Exclusion Criteria:

Age younger than 18 years. Cognitive impairment, severe psychiatric disorder, or communication problems preventing completion of questionnaires.

Previous major injury, surgery, or permanent functional impairment of the affected upper extremity.

Polytrauma or additional injuries that may substantially affect upper extremity function or rehabilitation outcomes.

Neurological disorders affecting upper extremity function (e.g., stroke, peripheral neuropathy, spinal cord injury).

Severe musculoskeletal disorders of the upper extremity unrelated to the index injury.

Inability or unwillingness to attend follow-up evaluations. Refusal to provide

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Minor Injury Group

    Participants with traumatic hand or forearm injuries classified as minor according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS \<20). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

    Other: Standard Surgical Treatment and Routine Postoperative Care

  • Experimental
    Moderate Injury Group

    Participants with traumatic hand or forearm injuries classified as moderate according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 21-50). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

    Other: Standard Surgical Treatment and Routine Postoperative Care

  • Experimental
    Severe Injury Group

    Participants with traumatic hand or forearm injuries classified as severe according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS 51-100). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

    Other: Standard Surgical Treatment and Routine Postoperative Care

  • Experimental
    Major Injury Group

    Participants with traumatic hand or forearm injuries classified as major according to the Modified Hand Injury Severity Classification (MHISC/MEYCS) score (MEYCS \>101). Patients will undergo standard surgical treatment and routine postoperative care and will be followed for assessment of kinesiophobia and functional outcomes.

    Other: Standard Surgical Treatment and Routine Postoperative Care

Interventions

  • OtherStandard Surgical Treatment and Routine Postoperative Care

    Participants with traumatic hand or forearm injuries will receive surgical treatment and postoperative management according to routine clinical practice and the treating surgeon's decision. No experimental treatment, device, medication, or rehabilitation protocol will be administered as part of the study. The study is observational in nature and aims to evaluate the relationship between early kinesiophobia levels, injury severity, and subsequent functional outcomes following standard surgical care.

    Also known as: Routine Clinical Management

06

What researchers measure

Primary outcomes

  1. Disabilities of the Arm, Shoulder and Hand (DASH) Score

    Functional disability and symptoms of the upper extremity assessed using the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. The study will evaluate the association between early kinesiophobia levels measured within 1-5 days after injury and functional outcomes at 12 weeks following surgically treated hand and forearm injuries.

    Time frame: 12 weeks after injury

Secondary outcomes

  1. Hand Grip Strength

    Grip strength of the injured hand measured using a standard hand dynamometer. Three measurements will be obtained and the mean value will be recorded.

    Time frame: 12 weeks after injury

  2. Buck-Gramcko Functional Score

    Hand function, pain, and range of motion assessed using the Buck-Gramcko scoring system to evaluate intermediate-term functional recovery.

    Time frame: 8 weeks after injury

  3. Sollerman Hand Function Test Score

    Hand function during activities of daily living assessed using the Sollerman Hand Function Test.

    Time frame: 8 weeks after injury

  4. Tampa Scale of Kinesiophobia (TSK) Score

    Fear of movement and reinjury assessed using the Turkish version of the Tampa Scale of Kinesiophobia during the acute post-injury period.

    Time frame: Within 1-5 days after injury

  5. Modified Hand Injury Severity Classification (MHISC/MEYCS) Score

    Injury severity assessed using the Modified Hand Injury Severity Classification (MEYCS) at the time of initial evaluation.

    Time frame: Within 1-5 days after injury

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Cantero-Tellez R, Rider J, Cruz-Gambero L, Villafane JH, Valdes K. Kinesiophobia, catastrophizing, and the duration of immobilization: A prospective study on factors associated with shoulder disability following wrist-hand injuries. J Hand Ther. 2025 Jul-Sep;38(3):477-482. doi: 10.1016/j.jht.2024.08.004. Epub 2025 Jan 6. PubMed 39765429 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Dec 2026, 6 months later.

Of 59 non-industry interventional studies with no phase under Hand Injuries, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 26. This study's planned 6 months is below that.

Counting every sponsor, half of 59 studies reached it within 14 months; a quarter within 8 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2026
First posted
Jun 25, 2026
StartEst.
Jun 19, 2026
Primary completionEst.
Dec 20, 2026
CompletionEst.
Mar 17, 2027
Last update
Jun 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07668544
Lead sponsor
Ebru Aloğlu Çiftçi
Responsible party
Ebru Aloğlu Çiftçi (Lecturer, Istinye University) — Sponsor-investigator
First posted
Jun 25, 2026
Start date
Jun 19, 2026 (estimated)
Primary completion
Dec 20, 2026 (estimated)
Completion
Mar 17, 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Samir İlgaroğlu, Surgeon
Contact
doktorsamir.zeynal@gmail.com
+905536166156

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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